Tuesday, April 5, 2016

Since enactment of the DQSA, FDA has: – Conducted over 230 inspections of compounders including approximately 60 inspections of compounders registered as outsourcing facilities – Approximately 80 of these inspections have been for-cause, generally based on reports of serious adverse events or product quality issues such as drug contamination



source FDA http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm491054.pdf

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